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FDA 510(k) Application Details - K123614
Device Classification Name
Nebulizer (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K123614
Device Name
Nebulizer (Direct Patient Interface)
Applicant
TRUDELL MEDICAL INTL.
725 THIRD ST.
LONDON N5V 5G4 CA
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Contact
DARRYL FISCHER
Other 510(k) Applications for this Contact
Regulation Number
868.5630
More FDA Info for this Regulation Number
Classification Product Code
CAF
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More FDA Info for this Product Code
Date Received
11/23/2012
Decision Date
03/11/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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